PainNCT00926887
Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery
A study testing Erchonia(R) EML Laser in people with Pain, run by Erchonia Corporation.
Trial summary
The goal of the clinical study was to see if applying low level laser light therapy to the breasts during breast implant surgery could lessen pain experienced by 24 hours after the surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Erchonia(R) EML Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jul 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Suitability for breast augmentation surgery based on the need for correction of a congenital deformity or condition such as: Amastia, Hypomastia, Hypoplasia, Pectus Carinatum, Pectus Excavatum, OR a cosmetic breast enhancement indication, including: Augmentation to increase breast size, correction of ptotic (drooping) or pendulous (sagging) breasts, recontouring to obtain enhanced breast shape.
- Bilateral breast augmentation indication only.
- 18 to 55 years, inclusive.
- Female, only.
- Willingness, and ability, to refrain from consuming over-the-counter and/or prescription medications for the indication of the relief of pain and/or swelling, including any non-steroidal anit-inflammatory drugs (NSAIDs), from 48 hours immediately prior to the laser-assisted breast implant procedure through to one week post-procedure.
Who cannot join
- Breast augmentation procedures indicated for the purpose of breast reconstruction following mastectomy or an injury due to severe trauma.
- Presence of a specific connective tissue disorder.
- Inadequate tissue available to cover the implants.
- Consumption of any one or more of narcotics, opiates, and/or steroids.
- Inability to consume the following medications post-operatively due to allergy, intolerance, or any other reason:
- Pain medication for the relief of post-operative pain of Lortab 10/500 or another drug within the combination narcotic analgesic drug category within which Lortab falls.
Show all 14Show fewer
- Antibiotic medication for reducing the risk of post-operative infection of Keflex 500 mg or Cipro 500 mg or another drug within the broad-spectrum antibiotic drug category within which Keflex and Cipro fall.
- Developmental disability or cognitive impairment that impacts a subject's ability to read and/or to understand the content of the informed consent form, and/or impacts a subject's ability to read and /or to understand and/or to complete the required case report form information for the clinical study.
- Significant psychological disorder(s) for which treatment has become necessary, including anxiety and depression; psychiatric hospitalization.
- Pregnancy or lactation.
- Prior surgery to the breast area, or to the area of the intended incision.
- Infection or wound in the intended areas of treatment.
- Involvement in litigation and/or receiving disability benefits related to the subject's breast(s).
- Participation in research over the preceding 90 days.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Evaluation of the Effect of the Erchonia(R) EML Laser on Reducing Pain Following Breast Augmentation Surgery
The goal of the clinical study was to see if applying low level laser light therapy to the breasts during breast implant surgery could lessen pain experienced by 24 hours after the surgery.
Read the detailed description
Substantial pain, discomfort and swelling following breast augmentation surgery is not uncommon. The ability of low level laser therapy to reduce swelling and inflammation that subsequently reduces pain has been well documented. This study aimed to evaluate the ability of low level laser therapy to reduce post-operative pain and swelling for individuals undergoing bilateral breast augmentation surgery, by 24 hours post-surgery.
- Conditions
- Pain
- Being tested
- Erchonia(R) EML Laser, Placebo Laser
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia(R) EML LaserDevice
Low level laser red light of 635 nm and delivering 1.5 joules/cm2.
Placebo LaserDevice
Inactive light
| Study group | Role | What they receive |
|---|---|---|
| Placebo Laser | Sham comparator | Placebo Laser is an inactive light Receives: Device: Placebo Laser |
| Erchonia EML Laser | Active comparator | Erchonia EML Laser uses two 7mW red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2. Receives: Device: Erchonia(R) EML Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.
Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below.
Measured: 24 hours post-operative
Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.
Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.'
Measured: 24 hours
Secondary outcomes (6)
Swelling Evaluation Through Length by Width Breast Diameter Measurements
Measured: immediately, 24 hours & 7 days post surgery
Self-reported Degree of Pain Rating in the Breasts Area.
Measured: 24 hours, 7 days, 14 days & 28 days post surgery
Use of Pain Management Medication Post-surgically.
Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.
Measured: Through the 1st 7 post-operative days.
Hydration Level Assessment
Measured: immediately, 24 hours & 7 days post surgery.
Infection Evaluation
Measured: 24 hours & 7 days post surgery
Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale
Measured: 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startSep 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert F Jackson, MD, FACS, Principal investigatorGregory Roche, DO, Principal investigatorThomas L Jackson, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926887
- Sponsor's protocol ID
- EBA-001
- Status last verified
- Apr 2014
- First submitted
- 22 Jun 2009
- Last updated
- 17 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Evaluation of the Effect of the Erchonia(R) EML Laser on Reducing Pain Following Breast Augmentation Surgery
- ClinicalTrials.gov ID
- NCT00926887
- Acronym / sponsor ID
- EBA-001
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Posted 6 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the clinical study was to see if applying low level laser light therapy to the breasts during breast implant surgery could lessen pain experienced by 24 hours after the surgery.
Detailed description
Substantial pain, discomfort and swelling following breast augmentation surgery is not uncommon. The ability of low level laser therapy to reduce swelling and inflammation that subsequently reduces pain has been well documented. This study aimed to evaluate the ability of low level laser therapy to reduce post-operative pain and swelling for individuals undergoing bilateral breast augmentation surgery, by 24 hours post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Laser | Sham comparator | Device: Placebo LaserPlacebo Laser is an inactive light |
| Erchonia EML Laser | Active comparator | Device: Erchonia(R) EML LaserErchonia EML Laser uses two 7mW red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Suitability for breast augmentation surgery based on the need for correction of a congenital deformity or condition such as: Amastia, Hypomastia, Hypoplasia, Pectus Carinatum, Pectus Excavatum, OR a cosmetic breast enhancement indication, including: Augmentation to increase breast size, correction of ptotic (drooping) or pendulous (sagging) breasts, recontouring to obtain enhanced breast shape.
- Bilateral breast augmentation indication only.
- 18 to 55 years, inclusive.
- Female, only.
- Willingness, and ability, to refrain from consuming over-the-counter and/or prescription medications for the indication of the relief of pain and/or swelling, including any non-steroidal anit-inflammatory drugs (NSAIDs), from 48 hours immediately prior to the laser-assisted breast implant procedure through to one week post-procedure.
Key exclusion criteria (14 listed)
- Breast augmentation procedures indicated for the purpose of breast reconstruction following mastectomy or an injury due to severe trauma.
- Presence of a specific connective tissue disorder.
- Inadequate tissue available to cover the implants.
- Consumption of any one or more of narcotics, opiates, and/or steroids.
- Inability to consume the following medications post-operatively due to allergy, intolerance, or any other reason:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erchonia(R) EML LaserLow level laser red light of 635 nm and delivering 1.5 joules/cm2. | Device | Erchonia EML Laser |
| Placebo LaserInactive light | Device | Placebo Laser |
Primary outcome
Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.
Time frame: 24 hours post-operative
Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below.
Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.
Time frame: 24 hours
Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.'
6 secondary outcomes
Swelling Evaluation Through Length by Width Breast Diameter Measurements
Time frame: immediately, 24 hours & 7 days post surgery
Self-reported Degree of Pain Rating in the Breasts Area.
Time frame: 24 hours, 7 days, 14 days & 28 days post surgery
Use of Pain Management Medication Post-surgically.
Time frame: Through the 1st 7 post-operative days.
Hydration Level Assessment
Time frame: immediately, 24 hours & 7 days post surgery.
Infection Evaluation
Time frame: 24 hours & 7 days post surgery
Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale
Time frame: 7 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA 510(k)#K072206 clearance listing resulting from the outcome of this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert F Jackson, MD, FACS principal investigator
Gregory Roche, DO principal investigator
Thomas L Jackson, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia(R) EML Laser in people with Pain, run by Erchonia Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. (time frame: 24 hours post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.